dose-ranging study of gsk233705b in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the efficacy and safety of gsk233705b compared with placebo in subjects with copd.


Eligibility criteria:
inclusion criteria: * a signed and dated written informed consent prior to study participation. * male or female adults. a female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at visit 1/visit 1a, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - screening through follow-up contact) * 40 to 80 years of age at visit 1 * an established clinical history of copd * current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1. * a post-albuterol/salbutamol fev1/fvc ratio of ≤0.70 and a post-albuterol/salbutamol fev1 of ≥35 and ≤70% of predicted normal values exclusion criteria: subjects meeting any of the following criteria must not be enrolled in the study: * women who are pregnant or lactating. * a current diagnosis of asthma. * known respiratory disorders other than copd including but not limited to α-1 antitrypsin deficiency as the underlying cause of copd, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease. * any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy) * clinically significant chest x-ray or computed tomography (ct) scan abnormalities within 6 months prior to visit 1 that are not believed to be due to copd. * use of oral corticosteroids or antibiotics for copd within 6 weeks prior to visit 1. * hospitalization for copd or pneumonia within 3 months prior to visit 1. * use of antibiotics for a lower respiratory tract infection within 30 days prior to visit 1. * clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities. * an abnormal and clinically significant 12-lead electrocardiogram (ecg) that results in active medical problem. * positive for hepatitis b or hepatitis c at visit 1. * a current malignancy or previous history of cancer in remission for \<5 years prior to visit 1 * a history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate. * medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholingeric. * medically unable to withhold albuterol/salbutamol for 6 hours prior to spirometry testing at each study visit or to withhold ipratropium (if applicable) for the 6-hour period prior to the first 3 study visits (ipratropium cannot be used after visit 3). * additional medications: unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to visit 1 (the investigator will discuss the specific medications) * use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to visit 1. * use of long-term oxygen therapy (ltot) or supplemental oxygen required for greater than 12 hours a day. oxygen use as needed is not exclusionary. * clinically significant sleep apnea that requires continuous positive airway pressure (cpap) * use of regular nebulized therapy * use of nocturnal positive pressure or non-invasive positive pressure ventilation (nippv) * participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to visit 1. * an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the above who is involved in this study * history of psychiatric disease, intellectual deficiency, poor motivation, substance abuse in the two years prior to visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study. * use of gsk233705b in previous studies.

Keywords: copd multicenter gsk233705b double-blind chronic obstructive pulmonary disease (copd) randomized